CeeNU has been shown to be useful as a single agent in addition to other treatment
modalities, or in established combination therapy with other approved chemotherapeutic
agents in the following:
Brain tumors - both primary and metastatic, in patients who have already
received appropriate surgical and/or radiotherapeutic procedures.
Hodgkin's disease - secondary therapy in combination with other approved
drugs in patients who relapse while being treated with primary therapy, or who
fail to respond to primary therapy.
DOSAGE AND ADMINISTRATION
The recommended dose of CeeNU in adult and pediatric patients as a single agent
in previously untreated patients is 130 mg/m² as a single oral dose every
6 weeks (see PATIENT INFORMATION and HOW
SUPPLIED: Directions to the Pharmacist). In individuals with compromised
bone marrow function, the dose should be reduced to 100 mg/m² every 6 weeks.
When CeeNU is used in combination with other myelosuppressive drugs, the doses
should be adjusted accordingly.
Doses subsequent to the initial dose should be adjusted according to the hematologic
response of the patient to the preceding dose. The following schedule is suggested
as a guide to dosage adjustment:
|Nadir After Prior Dose
||Percentage of Prior Dose to be
| ≥ 4000
|| ≥ 100,000
| < 2000
|| < 25,000
A repeat course of CeeNU should not be given until circulating blood elements
have returned to acceptable levels (platelets above 100,000/mm³; leukocytes
above 4000/mm³), and this is usually in 6 weeks. Adequate number of neutrophils
should be present on a peripheral blood smear. Blood counts should be monitored
weekly and repeat courses should not be given before 6 weeks because the hematologic
toxicity is delayed and cumulative.
CeeNU® (lomustine) Capsules are available in individual bottles of 20 capsules
NDC 0015-3032-20 100 mg capsules (Green/Green)
NDC 0015-3031-20 40 mg capsules (White/Green)
NDC 0015-3030-20 10 mg capsules (White/White)
CeeNU Capsules are stable for the lot life indicated on package labeling when
stored in well-closed containers at 25°C (77°F); excursions permitted
to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature].
Avoid excessive heat (over 40°C, 104°F).
Directions to the Pharmacist
The total dose prescribed by the physician can be obtained (to within 10 mg)
by determining the appropriate combination of capsule strengths. Only the appropriate
number of CeeNU capsules required for a single administration should be dispensed.
The appropriate number of capsules of each size should be placed in a single
vial. Each color-coded capsule is imprinted with the dose in milligrams. In
order to provide the proper dose of CeeNU, patients should be aware that there
may be 2 or more different types and colors of capsules in the container. Patients
should be told that CeeNU is taken as a single oral dose and will not be repeated
for at least 6 weeks.
Caution should be exercised when handling CeeNU Capsules. Procedures for proper
handling and disposal of anticancer drugs should be utilized. Several guidelines
on this subject have been published.1-4 To minimize the risk of dermal
exposure, always wear impervious gloves when handling bottles containing CeeNU
Capsules. CeeNU Capsules should not be broken. Personnel should avoid exposure
to broken capsules. If contact occurs, wash immediately and thoroughly. More
information is available in the references listed below.
1. NIOSH Alert: Preventing occupational exposures to antineoplastic
and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health
and Human Services, Public Health Service, Centers for Disease Control and Prevention,
National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication
No. 2004 165.
2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2.
Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
3. American Society of Health-System Pharmacists. ASHP guidelines
on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.
4. Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy
and biotherapy guidelines and recommendations for practice. (2nd ed.) Pittsburgh,
PA: Oncology Nursing Society.
Manufactured for: Bristol-Myers Squibb Company Princeton, NJ
08543 USA. Made in Italy. Revised: October 2010